Eli Lilly & Co.’s COVID-19 antibody treatment was approved for emergency use by the Food and Drug Administration on Monday, and Lilly shares jumped more than 3% in after-hours trading.
Lilly
LLY,
-0.28%
received an emergency-use authorization, or EUA, from the FDA for its monoclonal antibody treatment called bamlanivimab. President Donald Trump received a similar experimental antibody drug from Regeneron Pharmaceuticals Inc.
REGN,
-1.81%
on an emergency basis when he was sickened with the coronavirus last month.
Bamlanivimab is seen as a potential treatment for those with mild to moderate forms of the coronavirus. The study that led to Monday’s EUA showed reduced viral load as well as rates for symptoms and hospitalization, Lilly said in announcing the EUA on Monday.
“Data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus,” Chief Scientific Officer Daniel Skovronsky said in the announcement.
An EUA is not a full approval but a type of regulatory authorization used during the pandemic to speed up the process of bringing new therapies to market. Lilly said that it would immediately begin shipping the drug to distributor AmerisourceBergen
ABC,
+2.22%,
and has previously said it has the capacity to manufacture one million doses of the monotherapy in the fourth quarter.
Lilly shares rose more than 3% in after-hours trading after the temporary authorization was announced. The stock has gained 8.3% so far this year, as the S&P 500 index
SPX,
+1.17%
has increased 9.9%.
MarketWatch staff writer Jaimy Lee contributed to this article.
